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Contraception and the periodic well-woman visit


									  Contraception and the
Periodic Well-Woman Visit
 Dr Cam McIntyre
 Medical Director, Health Leadership International
 Seattle, Washington, US

 Presented by Dr. T. Doughten (Seattle University)

 Training Course in Reproductive Health Research
 Vientiane, 25 November 2009
              Learning Objectives
• Describe contraceptive options available in the
  United States and Lao PDR
• Describe 3 strategies for individualized contraceptive
       Goals of the Well-Woman Visit
• Promote health, well-being, healthy lifestyle choices
• Facilitate early detection of female cancers, other
  problems, STIs
• Promote healthy pregnancy
• Prevent unintended pregnancy
    Contraceptive Options Available in the U.S. Prior to
•   Abstinence
•   Fertility awareness
•   Barriers/Spermicides
•   Injectable (3 month)
•   Intrauterine devices (IUD)
•   Oral contraceptives
•   Female sterilization
•   Vasectomy
 Combination Hormonal Methods:
     Non-contraceptive Health Benefits
Reduction in:
• Endometrial and ovarian cancers
• Dysmenorrhea, menorrhagia, menstrual cycle
• Ectopic pregnancy, pelvic inflammatory disease
• Iron deficiency anemia
• Benign breast disorders
• Acne
                               Kaunitz AM. Rev Endocrine Metab Dis, 2002.
          Combination Hormonal Methods:

•   Smokers: age >35 years
•   Hypertension: uncontrolled or age >35 years
•   Diabetes: vascular disease or age >35 years
•   Migraines: with aura
•   Vascular disease: associated with Systemic Lupus
    Erythematosus (SLE)
    Combination Hormonal Methods: Contraindications
•   Personal history of breast cancer or thromboembolism
•   Coronary artery or cerebrovascular disease
•   Hepatic disease with abnormal liver function
•   Cholestatic jaundice with prior pregnancy or contraceptive
   Addressing Patient Concerns About Combination
• Future fertility
• Breast cancer
   – Not affected by OCs or DMPA
• Weight gain
   – No evidence that OCs cause weight gain
• Venous thromboembolism
   – Risk with OCs is half of risk during pregnancy
   Risk of Venous Thromboembolism
                               Annual risk per
     Group                   10,000 women (est.)
Non-pregnant OC non-users            0.4 – 1.1
OC users                             1.0 – 3.0
Pregnant women                       5.9

                            Adapted from Mishell DR Jr. Contraception. 1999.
        Fatality Risk in Perspective
Pregnancy                1 : 7,500
Road traffic accident    1 : 8,000
Playing soccer                  1 : 25,000
Railway accident                1 : 500,000
VTE in OC user age 20–24        1 : 500,000

                                    Overton C, Katz M. Practitioner. 1999.
                                            WHO Scientific Group, 1998.
                                Chang J. Morbid Mortal Weekly Rep. 2003.
New Contraceptive Options Now Available
              in the U.S.

• New OC formulations    • Standard Days
  and regimens             method (Cycle
• Intrauterine system    • Transdermal patch
• Non-surgical tubal     • Vaginal ring
• Single – rod Implant
   Current Extended Regimen Options
• New extended OC options
  – Monophasic and phasic
  – Cyclical and continuous
  – Customized
• Progestin-only options
  – DMPA injection
  – Levonorgestrel IUD
  – Single-rod Implant
        Advantages of Regulating Menses
• Reduced menorrhagia             • Reduced dysmenorrhea
  –   Idiopathic                      –   Primary
  –   Uterine fibroids                –   Endometriosis
                                      –   Uterine fibroids
  –   Adenomyosis
                                      –   Adenomyosis
  –   Coagulation/hematologic
      problems                    • Reduced anemia
• Reduced menstrual-
  related symptoms
                                                Sulak PJ, et al. Obstet Gynecol. 1997.
                                                    Kaunitz AM. Contraception. 2000.
                                Sucato GS, Gold MA. J Pediatr Adolesc Gynecol. 2002.
         Extended Regimen Candidates
•   Athletes
•   Women in the military
•   Adolescents
•   Mentally or physically handicapped women
      Any woman who prefers to menstruate less

                                            Kaunitz AM. Contraception. 2000.
                         Sucato GS, Gold MA. J Pediatr Adolesc Gynecol. 2002.
            Extended Regimen OC
• First available in 2003
• Brand name: Seasonale®
• Dedicated, extended 84/7 monophasic OC
  – 150 mg levonorgestrel/30 mg ethinyl estradiol per
    active tablet
            Extended Regimen OC
• Efficacy comparable to combination OCs or vaginal
• Requires clinician visit for prescription
• Safety profile comparable to OCs
• Contraindications/precautions same as for
  combination OCs

                                Anderson FD, Hait H. Contraception. 2003.
                                 Seasonale® prescribing information. 2003.
         Extended Regimen: Myths
• Hormonal contraceptive users need to bleed each
• Menstrual blood & iron build up without bleeding
• Uterine lining becomes unhealthy & needs to shed
• Extended use decreases future fertility
• Monthly menses needed to prove a woman is
  Levonorgestrel Intrauterine System

• Brand name : Mirena® in
• First available 2001
• T-shaped reservoir placed
  in uterine cavity
• Initially releases 20 g of
  levonorgestrel (LNG) per
              LNG IUD: Characteristics
•   Highly effective for 5 years
•   Requires office visit for insertion/removal
•   Initial irregular bleeding/spotting common
•   Progestin-related side effects possible

                                          Mirena® Prescribing Information. 2000.
    LNG IUD: Non-contraceptive Health Benefits

• Improves menorrhagia, dysmenorrhea, anemia
• Decreases menstrual symptoms in women with
  uterine fibroids or adenomyosis
• May decrease risk of PID, ectopic pregnancy

                                                  Gardner, et al. Lancet. 2000.
                        Luukkainen T. Steroids. 2000.                Hubacher
                                   D, Grimes DA. Obstet Gynecol Surv. 2002.
            LNG IUD: Candidates
• Women who seek safe, reliable, reversible, cost-
  effective, long-term contraception
• Women who are not candidates for, or prefer not to
  use, other reversible contraception
• Women contemplating sterilization who are not sure
  about making an irrevocable decision
• Women with menstrual symptoms that may improve
  with LNG IUD
             LNG IUD: Side Effects
• Irregular bleeding, amenorrhea
• Ovarian cysts
• Androgenic skin changes

                                   Mirena Product Information. 2000.
           Dispelling Myths: IUDs
• Infections are a frequent problem
• IUDs increase risk of STIs
• IUDs cause tubal infertility, especially in
• IUDs prevent implantation
• IUDs cause ectopic pregnancies
• U.S. women are not interested in intrauterine
         Non-Surgical Tubal Occlusion
• First available 2002
• Brand name: Essure®
• Tubal sterilization through hysteroscopic placement
  of micro-coil in fallopian tubes
      Non-Surgical Tubal Occlusion
• No reported pregnancies to date
• Candidates: women seeking permanent non-surgical
  birth control
• Performed in operating room or clinic outpatient
                Transdermal Patch
• First available 2002
• Brand name: OrthoEvra®
• Beige-colored patch applied
  once a week
  – Abdomen, buttock, upper outer
    arm, upper torso
• 150 g norelgestromin/20 g
  ethinyl estradiol delivered daily
  to systemic circulation

                                Ortho Evra™ Prescribing Information. Nov. 2001.
                Transdermal Patch
• Efficacy comparable to OCs
   – Failure rates may be increased in women 90 kg
• Fewer than 3% detach
• Eliminates need for daily pill-taking
• Young women may be able to use the patch
                 Transdermal Patch
• Side effects
  – Combination hormones in patch similar to OCs (e.g.,
    headache, nausea)
  – Application site reactions
  – Breast tenderness
• Same contraindications as combination OCs
• Candidates: appropriate for women who desire the
  convenience of a once-weekly regimen
                                Ortho Evra™ prescribing information. Nov. 2001.
                                             Sibai BM, et al. Fertil Steril. 2002.
                     Vaginal Ring

• First available 2002
• Brand name: NuvaRing®
• Flexible, unfitted ring
  placed in vagina
• 120 g etonorgestrel/15 g
  ethinyl estradiol delivered
  daily to systemic circulation

                                  NuvaRing® prescribing information. 2001.
                         Vaginal Ring

• Efficacy comparable to OCs
   – No data regarding effect of
      body weight on efficacy
• Fewer than 4% device-related
• Eliminates need for daily pill-
• Women may be able to use the
  ring more consistently than OCs
                                    NuvaRing® prescribing information. 2001.
                                      Roumen FJ, et al. Hum Reprod. 2001.
                     Vaginal Ring
• Contraindications/side effects
  – Contraindications similar to OCs
  – Local effects: leukorrhea, vaginitis, device-related events
• Candidates: Appropriate for women who desire
  convenience of a 3-week regimen

                                       NuvaRing® prescribing information. 2001.
    Future Contraceptive Options (U.S.)

       <2 years             3–10 years
• Other continuous   • Male hormonal and non-
  regimen products     hormonal methods
                     • Microbicide gels/lotions
                     • Non-steroidal selective
                       progestin agonists
        Emergency Contraception:
         An Essential Safety Net
• 3.0 million unintended pregnancies annually in the
  United States
  – 49% of all pregnancies
• Emergency contraception
  – Reduces pregnancy risk by 74%
  – Averted ~51,000 abortions in 2000
  – Highly cost-effective

                                    Henshaw SK. Fam Plann Perspect. 1998.
                                     Trussell, et al. Am J Public Health. 1997.
  Advance Provision of EC Helps Reduce
       Unintended Pregnancies
• Advance EC prescription recommended for all
  women at risk for pregnancy
• Women on reversible methods can:
  – Forget to (or can’t) get prescription renewed
  – Stop using, thinking method is no longer needed
  – Have a condom break or slip
• Women may be more inclined to use a barrier
  with EC backup
             Emergency Contraception
•       High dose progestin-only pills
    – Brand name: Plan B in USA and Prostonyl here
    – 0.75 mg levonorgestrel – take 2 tablets
•       Combined estrogen–progestin pills
    –    Copper-T IUD insertion
    – Brand name: Paragard®
          Emergency Contraception
More effective: Plan B®
• 1 tablet within 72 h; repeat in 12 h, or
• 2 tablets taken together

Least effective: Other Non-levonorgestrel OCs
• Regimen varies by product

                        Task Force on Postovulatory Methods of Fertility. Lancet. 1998.
                                                  Von Hertzen H, et al. Lancet. 2002.
                                       Ellertson C, et al. Obstet Gynecol. 2003 a & b.
          Emergency Contraception
• EC pills shown to be effective up to 5 days after
  unprotected sex
• Most effective if taken as soon as possible after
  unprotected sex
• Consider advance provision
            Post-EC Management
• During EC administration
  – Immediately: recommend condoms, diaphragm,
  – Day after completing EC: initiate OC, ring, patch
    (“Quick Start”)
• During next menstrual cycle
  – Consider longer-term hormonal methods (IUD,

                                            World Health Organization 1998.
  Enhancing Contraceptive Continuation
                                                                 Giving Women Their Method of

• Strategies to facilitate                           100
                                                                 Choice Facilitates Continuation

  continuation                                                                          choice

                                        Discontinuers (%)
                                                            80                          denied
   – Give women their                                                                   choice
     method of choice                                       60

   – Provide high-quality                                   40
   – Provide pretreatment
     and ongoing counseling                                 0

                                                      Pariani S, et al. Stud Fam Plann. 1991.
          RamaRao S, et al. Int Fam Plann Perspect. 2003. Lei ZW, et al. Contraception. 1996.
         Pretreatment Counseling Enhances Contraceptive Continuation

Continuation rate (%) at 1 year

                                  80                                Routine




                                   0    Type of counseling

                                                             Lei Z-W, et al. Contraception. 1996.
             Contraceptive Use in the USA: 2003

Percentage of Women Aged 15-50







      Sterilization   None   Pill   Condom Abstinence   Injectable   Patch   Natural    IUD          Other
      (male and                                                               Family           (diaphragm, ring,
                                                Method                       Planning         gel/foam, rods, EC)

                                                Ortho Pharmaceutical. 2003 Annual Birth Control Study.
        Optimizing Contraceptive Choice
• Start visit with discussion of future fertility plans
   – What are your childbearing plans?
• Discuss the patient’s positive and negative experiences
   – What has worked for you before?
   – What is your partner’s preference?
    Barriers to Successful Contraceptive Use
•   Poor clinician–patient communication
•   Patient and partner barriers
•   Clinician barriers
•   Inadequate provision of contraceptive services
       Effects of Miscommunication
• Miscommunication between patients and their health
  care provider(s) negatively affected use of a primary
  contraceptive method in 14% of women.
• 77% of women did not know about EC
  Reducing Clinician–Patient Barriers
• Identify and address clinician and patient barriers to
  successful contraceptive use
  – Physical, sociopolitical, financial, behavioral
  – Cultural issues
• Provide non-threatening environment
  – “Stirrup-free” initiation
  – Comfortable environment
• Provide all appropriate information about existing
  and newer methods
      Optimizing Contraceptive Choice:
          Determining Preferences
• Are you happy with your present contraceptive
• Have you heard about new methods?
• Would you like to try one of them or something
• Do you have any questions about anything?
• Did we meet your needs today?
       Helping the Patient Succeed
• Do you understand that this contraceptive method
  must be used as prescribed?
• How long do you think you will use this birth
  control method?
• Can you think of any barriers to using this method
  as directed?
• Will you let me know about adverse reactions as
  they occur?
• Are you willing to return for follow-up visits?
                                   Branden PS. J Nurse-Midwifery. 1998.
   Men: The Forgotten Component of
      Contraceptive Counseling
• Clinicians need to inform sexually active
  females and partners about
  – Condoms
  – Emergency contraception
  – Vasectomy
  – STI and HIV/AIDS
               Office Practice Tips
•   Have a “demo” kit available
•   Initiate OC use during office visit (Quick Start)
•   Insert vaginal ring in the office
•   Use IUD model, feel IUD
•   Use diaphragm models; feel and insert diaphragm in
             Office Practice Tips
• Keep condom samples in office
• Provide emergency contraception
• Provide brief, simple, clear written instructions
• Provide simple protocols for correct use to improve
  patient confidence
• Avoid unnecessary follow-up
Summary: Contraception and the Well-
           Woman Visit
• Changing clinical guidance for well-woman visit
• Changing contraceptive options
• Streamlined, thoughtful approaches to provision of
  birth control services can maximize patient success
• Clinician’s challenge: integrate changes into an
  efficient, productive practice

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